The Regorafenib tablet gains EU approval for the treatment of metastasized colorectal cancer (mCRC) in adults, whose disease has progressed even after treatment with standard drugs. Regorafenib was previously approved by the FDA in late May 2012 to treat patients with metastatic colorectal cancer. That initial approval of Regorafenib for unresectable colon cancer was based on the Phase III CORRECT trial, which was an international trial of 760 participants. Survival rates improved for 29 percent of the patients who received regorafenib, and there was a median overall survival of 6.4 months, as compared to a 5 month survival for patients who received the placebo.
The Regorafenib tablet, commercially known as Stivarga, is marketed by Onyx Pharmaceuticals and Bayer. In late August 2013 the companies announced the Stivarga approval, although the announcement comes as no surprise as there was an early indication of a pending EU approval by a European committee overseeing medicines for human use in June 2013.
In late February 2013, the FDA approved Regorafenib specifically for patients with gastrointestinal stromal tumor (GIST) that is unresectable. That approval was based on the results from a phase lll trial coined GRID.
Learn more about the previous trials and the FDA approvals from our March 2013 article: A New Approval from the FDA for Regorafenib.
Regorafenib CAS# 755037-03-7 is an oral multi-kinase inhibitor developed by Bayer which targets angiogenic, stromal and oncogenic receptor tyrosine kinase (RTK). Regorafenib shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition. Regorafenib is unique in that it binds to and inhibits the vascular endothelial growth factor receptors 2 and 3, as well as Raf kinases.
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